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FDA Update – Foreign Establishments Will be Required to Register and List with the FDA as well as Designate a US Agent

In a recent Fed. Reg. Announcement – [98N-1215] – the FDA is proposing that Foreign Establishments whose products are imported or offered for import into the US be registered with the FDA as well as identify a United States agent and would describe some of the agent’s responsibilities. These requirements would be for any company who manufactures human drugs, animal drugs, biological products and devices.

The FDA will require that the Foreign Establishment submit the name, address, and phone number of its United States agent as part of the registration information. The new regulation would require that the agent reside or maintain a place of business in the US and would allow the US agent to also be designated as the official correspondent.

The FDA is requesting comments on these new regulations by July 28th, 1999. For more information on this or a copy of the Fed Reg Announcement please contact mdi.

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